Z-1169-2021Class II

Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190...

Name: Z-1169-2021 Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190...
Creator: Boston Scientific Corporation
Published: 2021-01-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-01-19 / Open, Classified / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20)... on 2021-01-19. FDA classified it as Class II and gives the reason as "Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1169-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-19
Posted: 2021-03-04
Recalling firm: Boston Scientific Corporation
Product: Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.
Product code: FDI Snare, Flexible
Reason for recall: Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Root cause tag: packaging
FDA root cause: Process change control
Action: On 01/21/2021, Boston Scientific issued Urgent Medical Device Product Removal notices to customers via e-mail. The removal notice is due to an incomplete seal of the inner pouch which could result in a sterile barrier breach rendering the specified lots of polypectomy snare devices non-sterile.
Quantity in commerce: 335,788 units total (Domestic: 222,882, Foreign: 112,906)
Distribution: US nationwide distribution.
Product codes and lots: Outer box GTIN: 08714729855934 Inner pouch GTIN: 08714729861263 Lot/Batch#: 25053639 Outer box GTIN: 08714729855903 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24948407, 24670592, 24679619, 24676929, 24939628 Outer box GTIN: 08714729861300 Inner pouch GTIN: 087147298 61294 Lot/Batch#: 24770325, 24952552, 24665104 Outer box GTIN: 08714729861317 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24679614, 25054403 Outer box GTIN: 08714729861348 Inner pouch GTIN: 08714729861324 Lot/Batch#: 24772995

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1169-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1168-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-10	2021-03-04
Z-1169-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-10	2021-03-04
Z-1170-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-10	2021-03-04

Product code FDI

K133987Class IICaptivator Ii,single-Use Polypectomy SnaresBoston Scientific Corporation / cleared 2014-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)